Support device for endoscopic suturless anastomosis

ABSTRACT

A support device for endoscopic suturless anastomosis between tubular organs include at least a first tubular member provided with a longitudinal slit which permits introduction of the organs to be anastomosed in the device and additional second tubular members in physical continuity with the first tubular member through an opening on the first tubular member. The size of the opening is substantially equal to the luminal area of the second member. The inner and outer diameters of any radial cross section of the second members are constant along its length. The device allows apposition of the two tubular organs to be anastomosed in a variety of spatial patterns and their fixation to each other without sutures or clips, either manually or via remote control, and the creation of luminal continuity between them.

The present invention relates to a support device for use in suturlessanastomosis procedures, and a method for performing suturlessanastomosis. The method according to the invention will be referred toin the present specification as IKF-IS technique (Institutt forKirurgisk Forskning-Intervensjonssenteret).

The risk inherent in the performance of conventional cardiopulmonarybypass grafting (CABG) and the relatively frequent need forreintervention after percutaneous transluminal coronary angioplasty(PTCA) have caused a rising interest in developing thoracoscopy assistedprocedures that combine the patient-friendly nature of PTCA with thedurable benefits offered by CABG.

Three approaches are currently undergoing evaluation, none of whicheliminate the need for both cardiopulmonary bypass and thoracotomy. Asthese two procedures represent the primary causes of morbidity afterCABG, there is an urgent need for developing a minimally invasiveprocedure that can be performed on a beating heart, entirely underendoscopic-fluoroscopic guidance.

The IKF-IS technique has been envisaged to meet this need.

An important feature of this technique is that its use is not limited tothe coronary arteries. An IKF-IS anastomosis can be done in any vasculararea within reach of an endoscope. The range of use includes alsoextravascular tubular structures such as the esophagus, intestines,ureter, biliary ducts and fallopian tubes.

Suturless anastomosis of vessels is not a new concept. A large number ofanastomosis devices has been described in literature, though few of themhave passed the test of time.

Structurally sound anastomosis between vessels can be rapidlyestablished simply by apposing the vessel ends with interlockingexternal collars.

GB-B-1.413.191 describes a device for the eversion of hollow organs anda vascular stapling instrument incorporating same. The device optionallycomprises a rigid bush with a longitudinal slot or a rigid split bushcomprising two pivotally connected half-bushes which can be mechanicallydisengaged from each other. The bush forms an integral part of aninstrument used to evert the cut edges of the limbs of the tubular organto be anastomosed and temporarily approximate them so as to facilitatesuturing or placement of clips that will hold the edges together. Whenthe clips are in place, the instrument and the bush are removed. Thusthe device simply acts as an aid to the creation of an anastomosis andin no way removes the drawbacks to using sutures and clips for creatinganastomoses.

U.S. Pat. No. 4,917,087 describes devices, kits and methods fornon-suture end-to-end and end-to-side anastomosis that employ tubularconnection members having clip retaining elements and spring clips whichcomprise a ring-shaped body with separable opposed ends whereby acircular opening defined by the body can be enlarged.

Unfortunately, these anastomosis devices and others available today weredesigned for use at open surgery and are not appropriate for endoscopicplacement.

EP-A-781.528 describes a fastener for connecting severed blood vessels.The device has a plurality of miniature barbs which pierce the wall ofthe blood vessel and anchor the fastener in place. In one embodiment thefastener comprises a sheet provided on one of its surfaces with aplurality of barbs, the sheet can be rolled to a diameter smaller thanthat of the blood vessel, inserted into the blood vessel and unrolled sothat the barbs pierce and anchor in the inner wall of the blood vessel.The sheet can alternatively be wrapped round the blood vessel so thatthe barbs pierce and anchor to the outer wall of the blood vessel. Thebond strength of the device as tested is not adequate for clinical use,because the biologic response is not appropriate or the design does notprovide the structural strength to tolerate the expected loading forces(whether in shear or in tension is not specified in the document) at theinterface between the device and the vessel surface. The penetration ofthe vessel wall by the barbs on the device can cause separation of thelayers of the vessel wall, which in turn can lead to thrombus formationor dissection at the site. The damage to the vessel wall would logicallybe even more severe if the size of the barbs is increased. Barbs whichspontaneously retract, will leave behind holes in the vessel wall fromwhich bleeding could occur. From the description provided in claims 1and 2, it does not seem possible that these embodiments of the devicelend themselves to use via an endoscope. Besides, it is unclear how thebarbs will be prevented from inadvertedly engaging the adjacentoverlying layer as the device is being unfolded by the balloon.

Furthermore WO 98/52474, WO 94/27506, demonstrate devices for performinganastomosis, with and without eversion of the blood vessel respectively,while U.S. Pat. No. 5,254,113 describes the use of strips foranastomosis of intestines. None of these publications do, however,describe a sleeve and use of a sleeve to evert the blood vessels, use ofa transitional temperature range (TTR) material in an anastomosis deviceand an anastomosis device provided with metal collars. In addition, theuse of these devices involves the retention of an intraluminal foreignbody after anastomosis creation in direct contradiction to the inventionin the present application.

FR-A-1.518.083 describes a device for performing end to end and end toside anastomosis. In the embodiment adapted for end to side anastomosis,the device comprises a curved plate with a bore and a joint surroundingthe bore. The plate is glued to a first vessel, a hole is cut in saidvessel corresponding to said bore in the plate, and a muff containingthe second vessel is attached to the joint. The curved plate simplyprovides a surface area for the adhesive used to attach the joint to thefirst vessel. Said plate does not permit fastening to the first vesselsolely by mechanical means without an adhesive. It does not offer anyself-attaching capability. Hence, in case of adhesive failure during thehealing process, the curved plate will get dislodged with possiblycatastrophic consequences.

An alternative method that has recently been successfully used forcoronary artery bypass grafting on a beating heart is the Tullekentechnique. By the incorporation of excimer laser arteriotomy, thistechnique permits the creation of end-to-end bypass without interruptingflow in the diseased vessel. However at its present stage ofdevelopment, performance of a Tulleken anastomosis via an endoscope isnot feasible. The high costs related to the use of excimer lasersfurther restrict the benefits of the Tulleken technique from theperspective of minimally invasive coronary artery surgery.

The object of the present invention is therefore to provide a devicethat permits creation of a suturless anastomosis between vessels via anendoscope. This object is achieved by means of a device comprising atleast one tubular member, and characterized in that the tubular memberis provided with a longitudinal slit, which slit permits introduction ofthe anastomosed vessels in the device, and the device is adapted forattachment to the vessel without any damage to the vessels' walls.

The need for suturing is entirely eliminated by the invention, reducingdanger of vascular trauma.

The anastomosis is exteiiiuy supported by the device according to theinvention, this reduces the risk of acute structural failure, delayedaneurysm formation and in the presence of compliance mismatch, improvesthe long-term patency rate.

The invention will be explained in more detail with the help of thefollowing drawings, where:

FIGS. 1 and 2 show first (Type Ia) and second (Type Ib) embodiments ofthe invention for performing end-to-side anastomosis;

FIG. 3 shows a third (Type II) embodiment of the invention forperforming end-to-side anastomosis;

FIG. 4 shows a fourth (Type III) embodiment of the invention forperforming end-to-side anastomosis;

FIG. 5 shows a fifth embodiment of the invention for performingend-to-end anastomosis;

FIGS. 6A and 6B show sixth and seventh embodiments of the invention forperforming end-to-side anastomosis;

FIGS. 7A and 7B show eigth and ninth embodiments of the invention forperforming end-to-side anastomosis;

FIG. 8 shows a cross-section of a first alternative joint of the slit'sedges;

FIG. 9 shows a cross-section of a second alternative joint of the slit'sedges;

FIG. 10 shows a third alternative of the slit's edges;

FIG. 11 shows a first alternative embodiment of the fixation sleeve;

FIGS. 12A, 12B and 12C show second alternative embodiment of thefixation sleeve, and an alternative embodiment of the inner collar andof the anastomosis device;

FIGS. 13-20 illustrate an externally stented end-to-side anastomosis bymeans of the device according to the invention for outflow vessels thatcannot be circumferentially dissected;

FIGS. 21-24A and 24B illustrate an externally stented end-to-sideanastomosis by means of the device according to the invention foroutflow vessels which can be circumferentially dissected;

FIGS. 25-32 illustrate an externally stented end-to-side anastomosis bymeans of the device according to the invention.

FIGS. 33-37A and 37B illustrate an externally stented end-to-sideanastomosis by means of the device according to the invention.

FIGS. 38-39A and 39B illustrate an externally stented end-to-sideanastomosis by means of the device according to the invention.

FIGS. 40-46 illustrate an externally stented end-to-end anastomosis bymeans of the device according to the invention.

FIG. 1 shows a first embodiment of the invention to be used ifcircumferential dissection of the outflow vessel is not possible (e.g.in coronary artery bypass). This embodiment of the invention shows afirst tubular member 1 and a second tubular member 2, where the firsttubular member 1 is provided with a longitudinal slit 3. The slit 3 iswide and the edges are not in contact. This characteristic allows use ofthis embodiment of the invention in cases where the outflow vesselcannot be circumferentially dissected, by placing the first tubularmember as a “cap” on the vessel. The second tubular member 2 is attachedon the side of the first tubular member 1 opposite the slit. In thisembodiment of the invention, the second tubular member does not show aslit.

FIG. 2 shows a second embodiment in which the first member is a flatsheet.

FIG. 3 shows a third embodiment of the invention to be used ifcircumferential dissection of the outflow vessel is possible. Thisembodiment of the invention is similar to the embodiment in FIG. 1except that the second tubular member 2 is split too and it is attachedto the first tubular member 1 in such a way that both slits are incontact. The whole device is “hinged” round a longitudinal line intubular member 1 lying opposite to the slit 3. The term “hinged” in thiscase is to be understood as a minimum separation of the slit's 3 edges,that otherwise are in contact.

FIG. 4 shows a fourth embodiment of the invention adapted for performingend-to-side anastomosis, and where the tubular members 1 and 2 areparallel, and have slits 3 and 3′ respectively the tubular members 1 and2 can have different diameters (a,b) depending on the size of the vesselto be anastomosed. Slit 3′ is a longitudinal slit along the commoncentral plane of the device. The two halves of members 1 and 2 can bedistracted perpendicular to the longitudinal axis without plasticdeformation. Edges AB and CD are not in contact, the distance betweenthem will vary according to the diameters of members 1 and 2. In anembodiment adapted for use with outflow vessels that cannot becircumferentially dissected, edges EF and GH are not in contact. Inanother embodiment for use with outflow vessels that can becircumferentially dissected edges EF and GH are in contact or overlapeach other.

FIG. 5 shows another embodiment of the invention, adapted for performingend-to-end anastomosis. This embodiment comprises only one tubularmember 1, with a slit 3.

FIGS. 6A and 6B show two embodiments of the inner sleeve of the IKS-IFanatomosis kit for performing end-to-side anastomosis. The embodimentcomprises one tubular member without a slit with (FIG. 6A) or without(FIG. 6B) parallel edges.

FIGS. 7A and 7B show two embodiments of the fixation sleeve of theIKS-IF anatomosis kit for performing end-to-side anastomosis. Theembodiment comprises one funnel shaped tubular member without a slitwith (FIG. 7A) or without (FIG. 7B) parallel edges.

Several possibilities are envisaged for the slits' edge area, with theintention of giving the invention high flexibility in use.

In one alternative embodiment, the opposing edges of the slit areconfigured so that they mechanically lock on the application of acentripetal radial force. One possible configuration for this purpose isshown in FIG. 8, where the edges show a Z-profile.

FIG. 9 shows another possibility for connection of the slit's edges.This possibility consists in extending the slit's edges to formoverlapping flaps. The surfaces of the flaps facing each other can beprovided with a fastening material, e.g. Velcro strips.

FIG. 10 shows an alternative embodiment of linear free edges of the slitmember of the anastomosis device type Ia illustrated in FIG. 1.

FIG. 11 shows an alternative embodiment of the fixation sleeve. Thecylindrical segment of the fixation sleeve is reinforced with acylindrical mesh of a thermodynamic shape-memory metal (e.g. equiatomicnickel-titanium intermetallic compound such as nitinol) withtransitional temperature range (TTR) slightly above normal bodytemperature. Below the TTR, the mesh is in martensitic state and itsdiameter greater than that of the inner sleeve to simplify placement.Above TTR the metal moves into austenitic state and the cylinder shrinksin diameter to match the inner sleeve.

FIGS. 12A, 12B and 12C illustrate alternative embodiment of the fixation(2″) and inner (2′) sleeves and anastomosis device Ia. Metal collars 5are embedded in tubular member 2 of anastomosis device type Ia at itsjunction with tubular member 1, and in the corresponding edges of theinner collar (5′) and the fixation collar (5″). After the inner sleeveis mated to the fixation sleeve and the latter to tubular member 2 ofanastomosis device Ia (as illustrated in FIG. 36), the collars arecrimped together so that inner and fixation sleeves with the tubularorgan sandwiched between them is secured to tubular member 2 of theanastomosis device.

In a further embodiment of the anastomosis devices, a continuouswire/strip of a thermodynamic shape-memory metal (e.g. equiatomicnickel-titanium intermetallic compound such as nitinol) withtransitional temperature range (TTR) slightly above normal bodytemperature is embedded along the free edge of the anastomosis device.Below the TTR, the wire frame is in martensitic state and hencemalleable so that the device can be straightened, if necessary, tosimplify placement. Above TTR the metal moves into austenitic state andthe wire regains the shape in its memory, and the anastomosis devicerecovers its original configuration.

In another embodiment of the invention, the outer surface of thefixation sleeve and inner surface of the side-arm of anastomosis devicetype II have ridges and troughs respectively (or vice versa) that engagewhen the side-arm is closed around the fixation sleeve.

In yet another embodiment of the invention, the inner surfaces of theanastomosis device and fixation sleeve and both surfaces of the innersleeve are lined with an appropriate adhesive.

In yet another embodiment of the invention, the inner surfaces of theanastomosis device and inner sleeve are lined with appropriatepharmacologic agents.

In another embodiment of the invention, the anastomosis device will bereinforced with a mobile, coaxial, close-fitting collar that will bedrawn over the device to secure its closure.

It will be clear that any of the above mentioned embodiments can be usedtogether with any embodiment of the invention.

The invention will now be illustrated by way of examples of creation ofan anastomosis. These examples are only illustrative and do not in anyway limit the scope of the invention as set forth in the attached patentclaims.

EXAMPLE 1 Externally Stented End-to-side Anastomosis with an AnastomosisDevice (Type I or II [Y-shaped])(FIGS. 1-3) Alone, for Outflow VesselsWhich Cannot be Circumferentially Dissected (e.g. Left AnteriorDescending Artery)

It is assumed that the device is precoated with an single componentadhesive or the substrate of a two component adhesive. If the device isnot precoated with a single component adhesive/substrate oftwo-component adhesive, it is applied to the inner surface of theanastomosis device before it is introduced into the operative field.

1. Angiography of left anterior descending artery (LAD) is performed toidentify the best site for anastomosis, a skin marker is placed, and thecatheter removed (FIG. 1)

2. Angiography of left internal mammary artery is performed to identifyany anomaly that will hinder use of the vessel as a bypass, and thecatheter is left in situ (FIG. 13)

3. Left IMA is endoscopically dissected (FIG. 14)

4. The angiography catheter in left IMA is exchanged for an angioplastycatheter.

5. The angioplastic catheter is advanced in left IMA until its tip is atthe site selected for anastomosis, the balloon is inflated.

6. Two clip are placed on the vessel distal to the catheter tip, and thevessel divided in between, flush with catheter tip (FIG. 14).

7. Left anterior descending artery (LAD) is endoscopically dissected atthe site selected for anastomosis (FIG. 2).

8. The stump ofleft IMA is held with a pair of forceps and drawn intothe side-arm of a type I Y-shaped anastomosis device (FIGS. 1, 15A, 15Band 15C).

(Modification: If a two component adhesive is being used, theappropriate activator is sprayed on the stump of left IMA.)

9. The balloon is inflated apposing the wall of left IMA to the innersurface of the anastomosis device (FIGS. 15A, 15B and 15C).

(Modfication: If a photopolymerizable adhesive is being used, light ofan appropriate wavelength is beamed on the side-arm of the anastomosisdevice.)

10. The balloon is deflated and the catheter withdrawn a short distance.The balloon is reinflated.

11. The stump of left IMA protruding from the sidearm of the anastomosisdevice distal to the catheter tip is cut flush with the inner surface ofthe anastomosis device.

12. The edges of the anastomosis device are distracted and the device isplaced on the LAD. (FIG. 16).

(Modifications:

(i) If a two component adhesive is being used, the appropriate activatoris sprayed on the surface of LAD prior to placement of the anastomosisdevice.)

(ii) If a photoplymerizable adhesive is being used, light of anappropriate wavelength is beamed on the the anastomosis device after itis placed on LAD.

(iii) If the anastomosis device is made of/reinforced with athermodynamic alloy, physiologic saline at temperature higher than theTTR of the alloy is sprayed over the anastomosis device after it isplaced on LAD.

(iv) If a type Ib anastomosis device is being used, its flat componentis tamped down over LAD and its surrounding tissues.)

13. More adhesive is sprayed along the edges of the anastomosis device,and on its surface (FIG. 17).

14. A guidewire or an optical fibre is passed through the angioplastycatheter.

15. Using radiofrequency alternating current carried by the guidewire ora laser beam, the outflow vessel is perforated (FIG. 18).

16. The balloon is deflated and the catheter is advanced, and theanastomosis dilated (FIG. 18).

17. The balloon is deflated and the catheter is withdrawn into the leftIMA (FIG. 19).

18. The integrity of the anastomosis is endoscopically verified (FIG.20).

19. The angioplasty catheter is replaced with a Doppler guidewire, andpressure gradient across the anastomosis is measured.

20. The Doppler guidewire is replaced with an angiography catheter orendosonography catheter and an endoluminal examination performed.

21. Depending on the findings, a spasmolytic, thrombolytic isadministered, or the anastomosis redilated at higher pressures.

EXAMPLE 2 Externally Stented End-to-side Anastomosis with an AnastmosisDevice (type I or II [Y-shaped])(FIGS. 1-13) Alone, for Outflow VesselsWhich can be Circumferentially Dissected

Steps 1-7 are as described above in Example 1 (FIG. 21).

8. The balloon is inflated and the stump of left IMA cut flush with thetip of the catheter (FIG. 22).

9. A type II Y-shaped anastomosis support device (FIG. 3) is slippedaround the outflow vessel so that it fits snugly in the main stem of thesupport device (FIG. 23).

10. The stump of the outflow vessel is then placed in the side-arm ofthe support device so that it abuts the inflow vessel (FIG. 24A, 24B).The two halves of the anastomosis device are approximated and held thusfor a few minutes.

(Modifications:

(i) If a two component adhesive is being used, the appropriate activatoris sprayed on the surface of both outflow and inflow vessels prior toapproximating edges of the anastomosis device.

(ii) If a photoplymerizable adhesive is being used, light of anappropriate wavelength is beamed on the the anastomosis device after theedges are approximated.

(iii) If the anastomosis device is made of/reinforced with athermodynamic alloy, physiologic saline at temperature higher than theTTR of the alloy is sprayed over the anastomosis device after the inflowvessel is placed in the sidearm.

(iv) Radial compressive forces are applied to the anastomosis device ifit is equipped with adhesive/fixation strips or a locking mechanism.)

The rest of the procedure comprises steps 13-20 described above (Example1).

EXAMPLE 3 Externally Stented End-to-side Anastomosis with a Type III(Double-barrel) Anastomosis Device (FIG. 4) Alone

The same procedure is used irrespective of whether the outflow vesselcan be circumferentially dissected. The first four steps are the same asin Example 1.

5. The angioplasty catheter is advanced in left IMA until its tip is atthe site selected for anastomosis. The vessel is ligated at two sitesdistal to the catheter tip, and the vessel divided in between.

6. LAD is endoscopically dissected at the site selected for anastomosis.

7. The free edges of the type III anastomosis device (FIG. C) aredistracted and it is placed on the LAD (FIG. 25).

(Modifications:

(i) If a two component adhesive is being used, the appropriate activatoris sprayed on the surface of LAD prior to placement of the anastomosisdevice.

(ii) If the anastomosis device is made of/reinforced with athermodynamic alloy, physiologic saline at temperature higher than theTTR of the alloy is sprayed over the anastomosis device after it isplaced on LAD.)

(iii) Radial compressive forces are applied to the anastomosis device ifit is equipped with adhesive/fixation strips or a locking mechanism.)

8. The ligated stump of left IMA is held with a pair of forceps anddrawn into the vacant limb of the anastomosis device (FIG. 26).

(Modification:

(i) If a two component adhesive is being used, the appropriate activatoris sprayed on the stump of left IMA.)

9. The balloon is inflated apposing the external surface of IMA with theexternal surface of LAD and the luminal surface of the anastomosisdevice, facilitating the formation of cohesive adhesive bonds betweenthem (FIG. 27).

(Modfication:

(i) If a photopolymerizable adhesive is being used, light of anappropriate wavelength is beamed on the anastomosis device.

10. More adhesive is sprayed along the edges of the anastomosis device,and on its surface (FIGS. 28A and 28B).

11. The balloon is deflated and the catheter is withdrawn a shortdistance. The balloon is inflated and a torque-controlled guidewireintroduced through the catheter (FIG. 29).

12. Using radiofrequency alternating current carried by the guidewire,the adherent walls of IMA and LAD are perforated and the wire advancedto a secure position in the latter (FIG. 29).

13. The balloon catheter is advanced into LAD. The balloon is inflatedto dilate the anastomosis. The balloon is deflated and the catheter iswithdrawn into left IMA (FIG. 30).

The rest of the procedure comprises of steps 13-20 described in example1 (FIGS. 31, 32).

EXAMPLE 4 Externally Stented End-to-side Anastomosis with an IKF-ISAnastomosis Kit (FIGS. 1, 6A, 6B, 7A, 7B), for Outflow Vessels WhichCannot be Circumferentially Dissected (e.g. Left Anterior DescendingArtery)

It is assumed that the components of the kit are precoated with ansingle component adhesive or the substrate of a two component adhesive.If they are not pre-coated with a single component adhesive/substrate oftwo component adhesive, it is applied before the various components ofthe anatomosis kit are introduced into the operative field.

Steps 1-7 are as in Example 1.

8. The stump of left IMA is held with a pair of forceps and drawn intoan inner sleeve (FIGS. 33A, 33B, 33C).

9. The balloon is inflated apposing the wall of left IMA to the innersurface of the inner sleeve (FIGS. 6A and 6B).

10. While the inner sleeve is held in position a fixation sleeve (FIGS.7A, 7B) is drawn over it everting free edge of left IMA and fixing it tothe outer surface of the inner sleeve (FIG. 34).

(Modfications:

(i) If a two-component adhesive is being used, activator is sprayed onthe inner sleeve before the fixation sleeve is placed.

(ii) If the fixation sleeve is made of/reinforced with a thermodynamicalloy, physiologic saline at temperature higher than the TTR of thealloy is sprayed over the sleeve after it is drawn over the innersleeve.

(iii) If the inner and fixation sleeves have metal collars, they arecrimped securing the sleeves to each other.)

11. The fixation collar carrying the inflow vesssel is inserted into thesidearm of a type I anastomosis device (FIG. 36).

(Modfications:

(i) If a two-component adhesive is being used, activator is sprayed onthe fixation sleeve before it is placed in the side-arm.

(ii) If a photopolymerizable adhesive is being used, light of theappropriate wavelength is beamed on the sidearm.

(iii) If the the fixation sleeve and the side-arm of the anastomosisdevice have metal collars, they are crimped securing the sleeves to eachother.)

The rest of the procedure comprises steps 13-20 described under example1 (FIGS. 35, 37A, 37B).

EXAMPLE 5 Externally Stented End-to-side Anastomosis with an IKF-ISAnastomosis Kit (FIGS. 3, 6A, 6B, 7A, 7B), for Outflow Vessels Which canbe Circumferentially Dissected

Steps 1-10 are the same as for example 4.

11. A type II anastomosis device is slipped around the outflow vessel sothat it lies snugly in the stem of the anastomosis device (FIG. 38).

12. The fixation sleeve carrying the inflow vessel is then placed in thesidearm of the anastomosis device such that it abuts the outflow vessel.The two halves of the anastomosis device are approximated and held thusfor a few minutes (FIGS. 39A, 39B).

(Modifications:

(i) If a two component adhesive is being used, the appropriate activatoris sprayed on the surface of both outflow and inflow vessels prior toapproximating edges of the anastomosis device.

(ii) If a photoplymerizable adhesive is being used, light of anappropriate wavelength is beamed on the the anastomosis device after theedges are approximated.

(iii) If the anastomosis device is made of/reinforced with athermodynamic alloy, physiologic saline at temperature higher than theTTR of the alloy is sprayed over the anastomosis device after the inflowvessel is placed in the sidearm.

(iv) Radial compressive forces are applied to the anastomosis device ifit is equipped with adhesive/fixation strips or a locking mechanism).

The rest of the procedure comprises steps 13-20 of Example 1.

EXAMPLE 6 Externally Stented End-to-end Anastomosis

It is assumed that the anastomosis device/components of anatomosis kitare precoated with an single component adhesive or the substrate of atwo component adhesive. If the device is not pre-coated with a singlecomponent adhesive/substrate of two-component adhesive, it is applied tothe inner surface of the anastomosis device before it is introduced intothe operative field.

1. Angiography of the outflow vessel is performed to identify the bestsite for anastomosis, skin marker placed, and catheter is removed.

2. Angiography of the inflow vessel is performed to identify any anomalythat will hinder use of the vessel as a bypass.

3. The inflow vessel is endoscopically dissected.

4. The angiography catheter is exchanged for a triple-lumen,double-balloon catheter which is advanced till its distal balloon liesastride the site selected for anastomosis. The balloon is inflated andits midpoint marked on the adventitia. A clip is placed on the vesseldistal to the balloon (FIG. 40).

5. The proximal balloon is inflated and the distal balloon deflated. Thevessel is divided at the site marked on the adventitia (FIG. 41).

6. The outflow vessel is endoscopically dissected and a clip placed oneach side of the site selected for anastomosis. The vessel is dividedbetween the clips (FIG. 42).

7. The inflow and outflow vessels are aligned along a commonlongitudinal axis (FIG. 43).

8. The balloon catheter is introduced into the lumen of the outflowvessel and advanced until the divided edges of the two vessels abutagainst each other (FIG. 43). The distal balloon is inflated.

9. The anastomosis device is slipped around the vessels and gentlytamped against the inflated balloon (FIG. 44).

(Modifications:

(i) If a two component adhesive is being used, the appropriate activatoris sprayed on the surface of the outflow and inflow vessels prior toplacement of the anastomosis device.

(ii) If a photopolymerizable adhesive is being used, light of anappropriate wavelength is beamed on the anastomosis device afterplacement.

(iii) If the anastomosis device is made of/reinforced with athermodynamic alloy, physiologic saline at temperature higher than theTTR of the alloy is sprayed over the anastomosis device after it isplaced.

(iv) Radial compressive forces are applied to the anastomosis device ifit is equipped with adhesive/fixation strips or a locking mechanism).

10. More adhesive is sprayed along the seam of the anastomosis deviceand its edges and on its surface (FIG. 45).

11. Both balloons are deflated and the catheter withdrawn proximal tothe anastomosis (FIG. 45). The integrity of the anastomosis isendcoscopically verified (FIG. 46). If deemed necessary the pressuregradient across the anastomosis is measured followed by sonographic orradiographic examination. Depending on the findings, a spasmolytic orthrombolytic will be administered.

Based on the creation of a suturless anastomosis undervideoendoscopic-radiographic guidance, the IKF-IS technique representsan original concept that has this far not been investigated. If theunderlying hypothesis proves to be right, it could be the firstprocedure in a whole new family of minimally invasive reconstructiveprocedures that could be used in coronary circulation areas, in othervascular areas of the body and also at extravascular locations such asthe oesohagus, intestines, ureter, biliary ducts and fallopian tubes.

About 900-1000 percutaneous coronary angioplasties per millioninhabitants are performed annually in North America and Western Europe.Approximately half of these are related to a diseased left anteriordescending artery and can be treated by means of the IKF-IS technique.The IKF-IS procedure can also be a substitute for coronary bypassgrafting (300.000 procedures/year in the US) when the culprit lesionlies in the left anterior descending artery. In addition a substantialnumber of patients with multivessel disease can also benefit because theIKF-IS technique being radiographically guided can be easily combinedwith percutaneous angioplasty.

The above mentioned IKF-IS technique offers a simple, inexpensive optionthat can be used with endoscopic-fluoroscopic guidance. Antegrade flowin the outflow vessel will be stopped for only a few seconds, reducingthe possibility of ischaemic complications. Restrain of the cardiacmotion at the anastomosis is unnecessary, and thus expensive custom-madeinstruments or creation of cardioplegia and cardiopulmonary bypass areavoided.

Ostial stenosis reported as a consequence of use of laser in e.g. theTulleken technique may not represent a problem because the anastomosisis created by means of pneumatic dilation.

There is a clear need in the market for devices according to theinvention that make performance of suturless anastomosis in a safe andinexpensive way possible.

What is claimed is:
 1. A device for endoscopic suturless anastomosis oftubular organs selected from the group comprising blood vessels andextravascular tubular structures such as the esophagus, intestines,ureter, biliary ducts, fallopian tubes, etc., said device comprising afirst curved member and one or several second tubular members, whereinthe first curved member is a first tubular member provided with anopening for communication with the second tubular member, and a slitwhich extends longitudinally throughout the whole length of the firstcurved member, for placement of the device externally to said organs,such that the anastomosis is externally supported by the device; innersurfaces of the first and the second members are in continuity, suchthat the size of the opening on the side of the first member issubstantially equal to a luminal area of the second members; and innerand outer diameters of any radial cross section of the second member areconstant along the length of the second member.
 2. The anastomosisdevice according to claim 1, wherein an inner surface of the device islined with an appropriate adhesive.
 3. The anastomosis device accordingto claim 1, wherein the second tubular member is on one or both sidesprovided with a collar of thermodynamic shape memory metal or polymer.4. The anastomosis device according to claim 1, wherein the secondtubular member is arranged on an area of the first tubular memberopposite the slit.
 5. The anastomosis device according to claim 4,wherein the second tubular member is provided with a slit.
 6. Theanastomosis device according to claim 5, wherein the slits in the firstand second tubular members are in correspondence.
 7. The anastomosisdevice according to claim 1, wherein the first and second tubularmembers are parallel.
 8. The anastomosis device according to claim 1,wherein the one or more additional tubular members coaxially fit withinthe second tubular member of the anastomosis device in telescopicfashion, and that leading edges of these tubular members and the edge ofthe second tubular member in contact with the first curved member areprovided with biocompatible metal collars, wherein, the innermost metalcollar is most resistant to physical deformation.
 9. The anastomosisdevice according to claim 1, wherein the slits have edges that areconfigured to mechanically lock on the application of a radial force,e.g. with a Z-profile.
 10. The anastomosis device according to claim 1,wherein the slits have edges that form overlapping flaps and that thesurfaces of the flaps facing each other are provided with a fasteningmaterial, e.g. Velcro.
 11. The anastomosis device according to claim 1,wherein the device is provided along its free edges with a continuousstrip of a thermodynamic shape-memory metal with transitionaltemperature range above normal body temperature.
 12. The anastomosisdevice according to claim 1, wherein the device is reinforced with amobile, coaxial, close-fitting collar that will be drawn over the deviceto secure its closure.